Accelerating AAV biosafety testing to 1–2 weeks with validated NGS workflows

Next-generation sequencing (NGS) offers a faster route to biosafety and characterization testing, provided a single method can be validated to the standard expected under ICH Q5A(R2).

In this interactive webinar summary, Andrew Hillhouse (Principal Scientist, FUJIFILM Biotechnologies) shares how one NGS workflow was developed and validated for product identity, genome integrity and adventitious agent detection, with data on:

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Biosafety testing turnaround reduced from up to 8 weeks to 1–2 weeks

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Sensitivity down to roughly 4 copies of GFP per 100,000 copies of wild-type virus

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Validation across genomes from adeno-associated virus (AAV) vectors to the human genome

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